Caribou Medical Center

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure, direct observation, and interview with the laboratory manager on 12/4/2024, the laboratory failed to follow their policy and centrifuge urine at 400 g for urine sediment examinations. The findings include: 1. A review of the laboratory's policy, CMC - Laboratory Urinalysis & Microscopy Urine Analysis with Culture Criteria: "Centrifuge tubes for five (5) minutes at 400 g. (1500 rpm with a 15.25 cm radius head). " 2. A direct observation of the centrifuge on 12/4 /2024 at 10:51 am, the centrifuge displayed 600 RCF at 2200 RPM identified that the laboratory failed to follow their procedure. 3. In interview with the laboratory manager on 12/4/2024 at 10:51 am verified that the centrifuge setting was not following the facility's policy. 4. The laboratory performs 548 urine sediment examinations per year. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of the prothrombin time (PT) reagent cross over study documents, the Dade Innovin reagent package insert, a direct observation and an interview with the laboratory manager on 01/10/2023, the laboratory failed to use the correct international sensitivity index (ISI) and normal patient mean for patient International Normalized Ratio (INR) calculations. The findings include: 1. A review of the PT reagent cross over study documents identified a normal patient PT mean of 10.7 for the current Innovin lot number 549783. 2. A review of the Dade Innovin reagent package insert for lot 549783 identified an ISI of 1.08. 3. A direct observation of the ISI in the Sysmex CA620, the laboratory coagulation analyzer, identified an ISI of 1.07 and a patient mean of 10.4. The laboratory failed to use the correct ISI and patient mean to calculate the INR for patient reporting. 4. An interview with the laboratory manger on 01/10/2023 at 08:53 am confirmed that the laboratory was using the incorrect ISI and normal patient mean to calculate patient INRs since the new lot of reagents were put in use on 05/05/2021. 5. The laboratory reports performing 429 PT/INR tests annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D) and graded results from the American Association of Bioanalysts (AAB), the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2022 for the specialty of hematology. D2130 HEMATOLOGY CFR(s): 493.851(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a Proficiency Testing (PT) desk review of the Centers for Medicare and Medicaid (CMS) PT data report (Report 155D), graded PT results from the American Association of Bioanalysts (AAB) and telephone interview with the laboratory manager on 10/18/2022, the laboratory failed to successfully participate and achieve an overall satisfactory score for two (2) of three (3) testing events in 2022 for the specialty of hematology for the analyte white blood cell (WBC) differential. The findings include: 1. A PT desk review of Report 155D and graded PT results from AAB identified that the laboratory failed to achieve overall satisfactory scores for event one (1) and event two (2) in 2022 for the specialty of hematology for the analyte WBC differential. Analyte Year Event Score WBC Differential 2022 1 60% WBC Differential 2022 2 60% 2. A telephone interview with the laboratory manager on 10 /18/2022 at 4:24 pm confirmed the above findings. 3. The laboratory reports performing 872 Manual WBC Differential Tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a record review of patient test results, patient reports, manufacturers instruction for use (IFU) and an interview with the laboratory manager on 1/14/2022, the laboratory failed to report results as "less than" when the value was below the analytical measurement range (AMR). The findings include: 1. A review of the IFU identified that the AMR for urine protein on the Siemens Dimension EXL is 6-250 mg /dL. 2. A review of patient test results on the Siemens Dimension EXL from 1/4/2022 identified one patient, accession 2201040027, with a reportable range error that had a urine protein result of 4.9 mg/dL. 3. A review of the patient report for accession 2201040027 identified that the laboratory failed to report the urine protein result as "less than" 6. 4. An interview with the laboratory manager on 1/14/2022 at 9:20 am confirmed that the laboratory failed to report the above result as "less than" 6. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a random review of immunohematology quality control (QC) records, patient records and an interview with the laboratory manager on 4/20/2021, the laboratory failed to document control material results with graded or titered reactivity and include negative control material. The findings include: 1. A random record review of immunohematology QC and patient records for 2019, 2020 and 2021 identified that the laboratory failed to document positive QC (1-4+) and negative QC on 12/20/2019, 7/26/2020 and 10/13/2020 as required by regulation for ABO and Rh type, antibody screen and crossmatch testing. 2. One ABO and Rh type, antibody screen and crossmatch was performed on 12/20/2019. One ABO and Rh type, antibody screen and crossmatch was performed on 7/26/2020. One ABO and Rh type, antibody screen and crossmatch was performed on 10/13/2020. 3. An interview with the laboratory manager on 4/20/2021 at 10:00 am confirmed that immunohematology QC was not documented on 12/20/2019, 7/26/2020 and 10/13/2020. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a random record review of Quality Control (QC) documentation, instrument printouts and an interview with the laboratory manager on 4/19/2021 the laboratory failed to successfully perform two levels of of control material each 8 hours of operation. The findings include: 1. A random record review of QC documents and instrument printouts from the Sysmex CA-600 for 2019, 2020 and 2021 identified that the laboratory failed to perform two levels of QC for prothrombin time (PT) on 2/6 /2021. The laboratory performed one patient PT test on 2/6/2021. 2. An interview with the laboratory manager on 4/19/2021 at 3:18 pm confirmed that the laboratory failed to perform PT QC on 2/6/2021. -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) record review and an interview with the laboratory manager, the laboratory failed to enroll in a PT program that covers the type of testing performed in the specialty of bacteriology since the last survey on July 25, 2017. Findings: 1. A record review of the American Association of Bioanalysts PT documents revealed the laboratory failed to enroll in PT for the interpretation of gram stains. 2. An interview on December 10, 2018 at 9:35 A.M. with the laboratory manager, confirmed the microbiology laboratory failed to enroll for testing in gram stain interpretation. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) record review and an interview with the laboratory manager, the laboratory director or designee and the testing personnel failed to sign the attestation statements from the American Association of Bioanalysts (AAB) and the American Proficiency Institute (API). This is a repeat deficiency from the last survey on July 25, 2017. Findings: 1. A review of AAB and API PT records revealed the laboratory director or designee and the testing personnel failed to sign the attestation statements for the specialties of bacteriology, chemistry, hematology, immunohematology, endocrinology, toxicology, and virology for the three testing events reviewed in 2018 and event 3 in 2017. 2. An interview on December 10, 2018 at 9:35 A.M. with the laboratory manager, confirmed the laboratory failed to sign the attestation forms from AAB and API during the third event reviewed in 2017 and events 1, 2, and 3 in 2018. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on records review and an interview with the laboratory manager, the laboratory failed to retain quality control and patient test print-outs from the iSed instrument since the last survey on July 25, 2017. Findings: 1. A review of records for the iSed sedimentation rate instrument revealed the laboratory failed to retain quality control and patient test print-outs. 2. An interview on December 10, 2018 at 1:25 P.M. with the laboratory manager, confirmed the testing personnel failed to retain the quality control and patient test print-outs for the instrument. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if -- 2 of 4 -- applicable. This STANDARD is not met as evidenced by: Based on a review of patient test requisitions and an interview with the laboratory testing person, the laboratory failed to solicit the patients ' date of birth or sex and age from the 3 requisitions reviewed in February 2018. Findings: 1. A review of 3 patient test requisitions from February 2018, revealed the laboratory failed to document the patients ' date of birth or sex and age on the requisitions. 2. An interview on December 10, 2018 at 2:35 P.M. with the laboratory testing person, confirmed the laboratory failed to solicit and document the patient ' s date of birth. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on an observation, a record review, and an interview with the laboratory manager, the laboratory failed to document the expiration dates for the SediTrol sedimentation rate liquid quality controls since the last survey on July 25, 2017. Findings: 1. An observation at 1:15 P.M. of the laboratory, revealed an Alcor iSed instrument with two levels of SediTrol quality control vials in the rack without open or expiration dates on the vials. 2. A record review revealed the laboratory failed to maintain lot numbers, dates in use, and expiration dates of the quality control vials. 3. An interview on December 10, 2018 at 1:20 P.M. with the laboratory manager, confirmed the laboratory tested the quality control material until the vials were empty and did not know about the expiration dates for the material. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a record review of quality control results and an interview with the laboratory manager, the laboratory failed to ensure two levels of external quality control results for Prothrombin Time (PT) met the manufacturer's requirement for acceptability before reporting patient PT results for the time reviewed between September 2, 2018 and October 31, 2018. Findings: 1. A review of the Stago PT quality control results from September 2, 2018 through October 31, 2018 revealed 6 days when level 2 control was out of range and 1 day when level 1 was out of range. 2. An interview on December 10, 2018 at 2:00 P.M. with the laboratory manager, confirmed the laboratory failed to meet the manufacturer's quality control acceptability prior to reporting 7 patient PT results. -- 3 of 4 -- D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group by concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory manager, the laboratory failed to write a policy or procedure and failed to perform immediate spin compatibility testing to detect IgM antibodies since the last survey on July 25, 2017. Findings: 1. A review of blood bank documents revealed the laboratory failed write a procedure and failed to perform an immediate spin crossmatch for the detection of IgM antibodies for ABO incompatibilities. 2. An interview on December 10, 2018 at 11:55 A.M., with the laboratory manager, confirmed 2 out 3 testing personnel failed to perform an immediate spin to demonstrate ABO incompatibilities on patient specimens. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on patient record reviews, proficiency testing (PT) record reviews, and an interview with the laboratory manager, the laboratory failed to maintain test records to include the dates of bacteriology test performances and the testing personnel who performed bacteriology workups such as culture set-up on media, colony description and quantitation, and gram stains since the last survey on July 25, 2017. Findings: 1. A review of the American Proficiency Institute bacteriology PT worksheets revealed the laboratory failed to document culture procedures that include: a. the type of media used, b. the colony description, quantitation, and morphology, c. the individual performing each step of testing from streaking of the plate to final reporting, d. and the lot numbers and dates of each test performance. 2. A review of patient test records revealed the laboratory failed to identify the dates, testing personnel, and bacteriology tests performed on culture workups. 3. An interview on December 10, 2018 at 3:05 P. M., with the laboratory manager, confirmed the laboratory failed to document all bacteriology tests performed. -- 4 of 4 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on proficiency testing desk review, the laboratory failed to successfully participate in proficiency testing for the analyte Prothrombin time (PT). Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on proficiency testing (PT) desk review and the laboratory's graded PT results from American Association of Bioanalysts (AAB), the laboratory failed to achieve successful performance for the analyte Prothrombin time (PT) in two out of three testing events. Findings: Analyte Year Event Score PT 2017 1 60% PT 2017 3 60% -- 2 of 2 --